Koo 2006.
Methods | Double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group S = 40.8 ± 11.2, Group L = 41.3 ± 9.9, Group K10 = 40.3 ± 11.3, Group K50 =45 ± 10.5, Group K100 = 39.5 ± 11.7, Group KP 43.4 ± 11.8, Group Pre 37.3 ± 11.8, Group M = 40.4 ± 11.4 Gender (M:F): Group S = 11:19, Group L = 5:25, Group K10 = 13:17, Group K50 = 10:20, Group K100 = 12:18, Group KP = 13:17, Group Pre = 18:12, Group M = 22:8 Inclusion criteria: age 19 years to 59 years old, ASA I‐II, elective surgery Exclusion criteria: patients taking sedatives or analgesics, and those with allergic, neurologic, or cardiovascular disease Recruitment: 240 adult patients randomly assigned (30 in each group) Setting: Korea |
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Interventions |
Pretreatment alone Randomly allocated into eight groups; five groups during the first part of the study and three groups during the second part In Part 1, patients received pretreatment saline 2 ml (Group S) 2% lidocaine 2 ml (40 mg) (Group L) ketamine 10 mcg/kg (Group K10) ketamine 50 mcg/kg (Group K50) ketamine 100 mcg/kg (Group K100), respectively, immediately followed by propofol 2.5 mg/kg In Part 2, ketamine (100 mcg/kg) was administered 3 min before propofol (Group Pre) ketamine (100 mcg/kg) mixed with propofol solution and administered immediately after 2 ml saline (Group KP) ketamine (100 mcg/kg) administered just before injection of propofol in patients premedicated with midazolam (7.5 mg orally) 90 min before arrival in the operating room (Group M) |
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Outcomes | Pain intensity assessed on 4‐point scale 0 = no pain 1 = mild pain 2 = moderate pain 3 = severe pain associated with grimacing, withdrawal movement of forearm, or both Outcomes reported and used
Outcomes sought but not reported
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Notes | Period of the study: dates not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | N/A |
Allocation concealment (selection bias) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All syringes of test solution were prepared by a doctor not involved in induction of anaesthesia and covered so that the investigator who assessed the patient response was unaware of the nature of the solution." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "An anaesthesiologist blinded to the study group monitored each patient’s pain score at 5 sec intervals. All syringes of test solution were prepared by a doctor not involved in induction of anaesthesia and covered so that the investigator who assessed the patient response was unaware of the nature of the solution." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | N/A |
Other bias | Low risk | The study appears to be free of other sources of bias |